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Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)

Soybean MON 87705 × MON 87708 × MON 89788 (three‐event stack soybean) was produced by conventional crossing to combine three single soybean events: MON 87705, MON 87708 and MON 89788. This combination is intended to alter the fatty acid profile in the seed (in particular increasing the levels of ole...

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Autores principales: Naegeli, Hanspeter, Bresson, Jean‐Louis, Dalmay, Tamas, Dewhurst, Ian Crawford, Epstein, Michelle M, Firbank, Leslie George, Guerche, Philippe, Hejatko, Jan, Moreno, Francisco Javier, Mullins, Ewen, Nogué, Fabien, Rostoks, Nils, Sánchez Serrano, Jose Juan, Savoini, Giovanni, Veromann, Eve, Veronesi, Fabio, Álvarez, Fernando, Ardizzone, Michele, De Sanctis, Giacomo, Dumont, Antonio, Devos, Yann, Gennaro, Andrea, Gómez Ruiz, Jose Ángel, Lanzoni, Anna, Neri, Franco Maria, Papadopoulou, Nikoletta, Paraskevopoulos, Konstantinos, Raffaello, Tommaso
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10464710/
https://www.ncbi.nlm.nih.gov/pubmed/37649527
http://dx.doi.org/10.2903/j.efsa.2020.6111
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author Naegeli, Hanspeter
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Álvarez, Fernando
Ardizzone, Michele
De Sanctis, Giacomo
Dumont, Antonio
Devos, Yann
Gennaro, Andrea
Gómez Ruiz, Jose Ángel
Lanzoni, Anna
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
Raffaello, Tommaso
author_facet Naegeli, Hanspeter
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Álvarez, Fernando
Ardizzone, Michele
De Sanctis, Giacomo
Dumont, Antonio
Devos, Yann
Gennaro, Andrea
Gómez Ruiz, Jose Ángel
Lanzoni, Anna
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
Raffaello, Tommaso
collection PubMed
description Soybean MON 87705 × MON 87708 × MON 89788 (three‐event stack soybean) was produced by conventional crossing to combine three single soybean events: MON 87705, MON 87708 and MON 89788. This combination is intended to alter the fatty acid profile in the seed (in particular increasing the levels of oleic acid) and tolerance to glyphosate‐based and dicamba herbicides. The Genetically Modified Organisms Panel previously assessed the three single soybean events and did not identify safety concerns. No new data on the single soybean events, leading to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the three‐event stack soybean does not give rise to food and feed safety and nutritional concerns. In the case of accidental release of viable three‐event stack soybean seeds into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and the reporting intervals are in line with the intended uses of soybean MON 87705 × MON 87708 × MON 89788. Considering the altered fatty acid profile of the three‐event stack soybean, a proposal for post‐market monitoring needs to be provided by the applicant. The GMO Panel notes that in the context of this application EFSA‐GMO‐NL‐2015‐126 the applicant did not provide a 90‐day study on MON 87705 soybean in line with the applicable legal requirements. Therefore, the GMO Panel is not in the position to finalise the risk assessment of soybean MON 87705 × MON 87708 × MON 89788 under the current regulatory frame.
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spelling pubmed-104647102023-08-30 Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126) Naegeli, Hanspeter Bresson, Jean‐Louis Dalmay, Tamas Dewhurst, Ian Crawford Epstein, Michelle M Firbank, Leslie George Guerche, Philippe Hejatko, Jan Moreno, Francisco Javier Mullins, Ewen Nogué, Fabien Rostoks, Nils Sánchez Serrano, Jose Juan Savoini, Giovanni Veromann, Eve Veronesi, Fabio Álvarez, Fernando Ardizzone, Michele De Sanctis, Giacomo Dumont, Antonio Devos, Yann Gennaro, Andrea Gómez Ruiz, Jose Ángel Lanzoni, Anna Neri, Franco Maria Papadopoulou, Nikoletta Paraskevopoulos, Konstantinos Raffaello, Tommaso EFSA J Scientific Opinion Soybean MON 87705 × MON 87708 × MON 89788 (three‐event stack soybean) was produced by conventional crossing to combine three single soybean events: MON 87705, MON 87708 and MON 89788. This combination is intended to alter the fatty acid profile in the seed (in particular increasing the levels of oleic acid) and tolerance to glyphosate‐based and dicamba herbicides. The Genetically Modified Organisms Panel previously assessed the three single soybean events and did not identify safety concerns. No new data on the single soybean events, leading to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the three‐event stack soybean does not give rise to food and feed safety and nutritional concerns. In the case of accidental release of viable three‐event stack soybean seeds into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and the reporting intervals are in line with the intended uses of soybean MON 87705 × MON 87708 × MON 89788. Considering the altered fatty acid profile of the three‐event stack soybean, a proposal for post‐market monitoring needs to be provided by the applicant. The GMO Panel notes that in the context of this application EFSA‐GMO‐NL‐2015‐126 the applicant did not provide a 90‐day study on MON 87705 soybean in line with the applicable legal requirements. Therefore, the GMO Panel is not in the position to finalise the risk assessment of soybean MON 87705 × MON 87708 × MON 89788 under the current regulatory frame. John Wiley and Sons Inc. 2020-05-18 /pmc/articles/PMC10464710/ /pubmed/37649527 http://dx.doi.org/10.2903/j.efsa.2020.6111 Text en © 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Naegeli, Hanspeter
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Álvarez, Fernando
Ardizzone, Michele
De Sanctis, Giacomo
Dumont, Antonio
Devos, Yann
Gennaro, Andrea
Gómez Ruiz, Jose Ángel
Lanzoni, Anna
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
Raffaello, Tommaso
Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)
title Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)
title_full Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)
title_fullStr Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)
title_full_unstemmed Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)
title_short Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)
title_sort assessment of genetically modified soybean mon 87705 × mon 87708 × mon 89788, for food and feed uses, under regulation (ec) no 1829/2003 (application efsa‐gmo‐nl‐2015‐126)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10464710/
https://www.ncbi.nlm.nih.gov/pubmed/37649527
http://dx.doi.org/10.2903/j.efsa.2020.6111
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